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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03709953
Other study ID # Spark-AL003
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 19, 2018
Est. completion date April 30, 2021

Study information

Verified date October 2018
Source Guangzhou Institute of Respiratory Disease
Contact Chengzhi Zhou, professor
Phone 13560351186
Email doctorzcz@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Currently, there is no standard treatment for primary pulmonary lymphoepithelioid carcinoma. Apatinib is a new kind of Vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitors (TKIs). A disease-control rate of 75% was found in lung cancer patients in a phase II clinical study. Therefore, researchers hope to explore the efficacy and safety of apatinib in the treatment of primary pulmonary lymphoepithelioid carcinoma.


Description:

This study is a prospective, exploratory clinical trial. The purpose of this study was to evaluate the efficacy and safety of apatinib monotherapy in the treatment of primary pulmonary lymphoepithelioid carcinoma.

Thirty-three cases of pulmonary lymphoepithelioid carcinoma were enrolled in this study.

The primary endpoint was median progression-free survival.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apatinib
500 mg,po,QD; 28 days every cycle

Locations

Country Name City State
China Zhou Chengzhi Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (14)

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Outcome

Type Measure Description Time frame Safety issue
Other KPS Karnofsky Performance Scale 24 months
Primary PFS Median progression-free survival 24 months
Secondary OS Median overall survival 24 months
Secondary ORR Objective Response Rate 24 months
Secondary DCR Disease control rate 24 months
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